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Evaluation of the Accuracy and Safety of Regadenoson Injection as A Stress Drug of Myocardial Perfusion Imaging (MPI), A Multicenter, Random, Open, Adenosine Positive Control trial

Evaluation of the Accuracy and Safety of Regadenoson Injection as A Stress Drug of Myocardial Perfusion Imaging (MPI), A Multicenter, Randomized, Open, Adenosine Positive Control trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014649
Enrollment
Unknown
Registered
2018-01-26
Start date
2017-05-01
Completion date
Unknown
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

Gold Standard:The coronary angiography are judged positive if the stenosis of coronary arteries equal or larger than 50% in one of three main coronary arteries or their primary branches
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Sponsors

Fudan University Affiliated Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Clinical suspicion or known diagnosis of coronary heart disease patients who had been referred for (1) Coronary angiography within 14 days after drug stress, or (2) Having had coronary angiography within 14 days before drug stress, but without PCI (stents or balloon). 3. Patients understanding the research procedure, and providing written informed consent approved by EC.

Exclusion criteria

Exclusion criteria: 1) Revascularization procedure previously; 2) First degree Atrioventricular block with PR interval > 240ms; 3) Second or third degree Atrioventricular block; 4) Sick sinus syndrome, and atrial fibrillation with prolonged R-R interval, > 3s; 5) III to IV cardiac insufficiency; 6) Planning cardiac transplantation within 30 days; 7) Acute myocardial infarction in 1 week(ST-segment depression> 2mm or elevation); 8) Resting angina attacks in 48 hours; 9) Hemorrhagic stroke occurred in 6 months; 10) Clinically diagnosed as hypertrophic cardiomyopathy, acute myocarditis or pericarditis, or severe aortic stenosis; 11) Uncontrolled hypertension, SBP =180 mmHg or DBP =110 mmHg; 12) Symptomatic hypotension, SBP 1.5ULN, Cr>1.5 ULN; 15) Known to have malignant neoplasms; 16) Usage of beta-blockers and nitrates (excluding nitroglycerin) within 48 h; 17) Dipyridamole use within 24 h; 18) Consumption of theophylline, or caffeinated soft drinks within 12 h; 19) Use of sublingual nitroglycerin within 2h; 20) Known hypersensitivity to adenosine; 21) Pregnant or lactating women; 22) Unable to judge or unconsciousness; 23) Mental handicap, or severe emotional/mental disability; 24) Participation in another investigational drug study within 3 months; 25) Any condition unsuitable for the study judged by investigators.

Design outcomes

Primary

MeasureTime frame
Drug stress myocardial perfusion imaging;6/5000 Guanzhuàng dòngmài zàoying Coronary angiography;

Countries

China

Contacts

Public ContactHongCheng Shi

Fudan University Affiliated Zhongshan Hospital

bigstone_good@163.com+86 021-64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026